Olympus issues 'urgent' steps for cleaning device linked to superbugs

Last Updated: 2015-03-26

By Sharon Begley

NEW YORK (Reuters) - The largest manufacturer of medical devices at the center of recent superbug outbreaks in the U.S. issued an "urgent safety notification" to health providers on Thursday, detailing new procedures for disinfecting duodenoscopes and urging them to adopt the procedures "as soon as possible."

Manufacturer Olympus Corp said in a 13-page letter that a small-bristle brush required for the new cleaning procedures would be shipped "no later than May 8."

Olympus did not directly address whether the devices are safe to use until then and whether patients should, if possible, postpone procedures using the devices until hospitals have received the crucial brush. But until then, the company recommended cleaning the duodenoscope in accordance with the old instructions.

Duodenoscopes are used for endoscopic retrograde cholangiopancreatography (ERCP). More than 500,000 ERCPs using duodenoscopes are performed in the U.S. annually, usually to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions.

Because the devices are reusable, they are supposed to be thoroughly cleaned after each use so pathogens are not transferred from one patient to the next.

After seven patients at the Ronald Reagan UCLA Medical Center were exposed to antibiotic-resistant bacteria apparently spread by improperly disinfected Olympus duodenoscopes, including two who died, federal regulators determined that microbes could spread even when the manufacturer instructions were followed.

The problem was the design of the instruments, regulators determined, in particular a movable part called the elevator that the Food and Drug Administration (FDA) described as "extremely difficult to access."

In its letter, Olympus now recommends raising and lowering the elevator mechanism three times while the device is immersed in a disinfectant.

In addition, an area around the elevator must be cleaned with two different-sized brushes, one that hospitals already use and one that Olympus will ship by May 8.

The FDA has signed off on Olympus's instructions. The agency reiterated them in its own safety communication which it issued before the brushes are available "so that facilities can adopt the new high level disinfection steps immediately and begin training" personnel.